US FDA issues guidance to support generic drug development

The US Food and Drug Administration has published product-specific guidance for generics drugmakers with the goal of facilitating pipeline development and promoting access.

Product-specific guidances (PSGs) provide recommendations for developing generic drugs, helping companies to understand the evidence that they need to generate in order to secure a regulatory approval.

As well as enabling greater competition in the market, the FDA said it wanted to “support greater access to safe, effective, and potentially lower-cost treatments.”